# K252424: Anti-HCV Next

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 28, 2026 after 270 days
- Product code: MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3169
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P190011 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P190011: LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab, DiaSorin, Inc. (2019) Summary page 6.

## Indications for use
The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system. The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease. Not cleared for use in screening blood, plasma, or tissue donors.

Source page: https://510kreport.com/device/K252424
Methodology: https://510kreport.com/methodology